Nexviazyme® (avalglucosidase alfa-ngpt) – New orphan drug approval

The FDA announced the approval of Sanofi’s Nexviazyme (avalglucosidase alfa-ngpt), for the treatment of patients 1 year of age and older with late-onset Pompe disease (LOPD) [lysosomal acid alpha-glucosidase (GAA) deficiency]. August 6, 2021

Duexis® (ibuprofen/famotidine) – First-time generic

Alkem launched an AB-rated generic version of Horizon’s Duexis (ibuprofen/famotidine) tablets. August 4, 2021

Istodax® (romidepsin) – Indication withdrawal

Bristol-Myers Squibb (BMS) announced that the company plans to voluntarily withdraw the indication for Istodax (romidepsin) as monotherapy for the treatment of peripheral T-cell lymphoma (PTCL) in adult patients who have received at least one prior therapy. August 2, 2021